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Center for Drug Evaluation and Research (CDER)

946 FDA 510(k) clearances · Issuing office

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RecordFirmDate
YangZhou SuXiang Medical Instrument Co., Ltd. - FDA Warning Letter (2024-07-08)2024-07-08
Premier Manufacturing Products, LLC - FDA Warning Letter (2024-07-02)2024-07-02
reBom Co., Ltd. - FDA Warning Letter (2024-06-26)2024-06-26
Ozempen.com - FDA Warning Letter (2024-06-24)2024-06-24
Laboratorio Magnachem International - FDA Warning Letter (2024-06-18)2024-06-18
Sun Pharmaceutical Industries Limited - FDA Warning Letter (2024-06-18)2024-06-18
Vegewax Candleworx Ltd. - FDA Warning Letter (2024-06-14)2024-06-14
GFA Production Xiamen Co., Ltd. - FDA Warning Letter (2024-06-13)2024-06-13
Landy International - FDA Warning Letter (2024-06-12)2024-06-12
Aqualex Co., Ltd. - FDA Warning Letter (2024-06-12)2024-06-12
Angela D. Ritter, M.D. - FDA Warning Letter (2024-06-07)2024-06-07
Yahon Enterprise Co., Ltd. - FDA Warning Letter (2024-06-05)2024-06-05
TCT Nutraceuticals SDN. BHD - FDA Warning Letter (2024-06-05)2024-06-05
Fancystage Unipessoal, LDA - FDA Warning Letter (2024-06-04)2024-06-04
Aruba Aloe Balm N.V. - FDA Warning Letter (2024-05-13)2024-05-13
Natuzen Co., Ltd. - FDA Warning Letter (2024-05-03)2024-05-03
Kevin R. Bender, M.D./DBC Research Corporation - FDA Warning Letter (2024-05-02)2024-05-02
Ward Smelling Salts - FDA Warning Letter (2024-04-30)2024-04-30
Grupo Quimico SRL - FDA Warning Letter (2024-04-30)2024-04-30
Global Cosmetics Company Limited - FDA Warning Letter (2024-04-30)2024-04-30
www.dashpct.com - FDA Warning Letter (2024-04-24)2024-04-24
Zen Enterprises LLC - FDA Warning Letter (2024-04-18)2024-04-18
Dr Sankunni’s Ayurvedic Research Foundation Private Ltd. - FDA Warning Letter (2024-04-18)2024-04-18
C&T Dream Co., Ltd. - FDA Warning Letter (2024-04-11)2024-04-11
Natco Pharma Limited - FDA Warning Letter (2024-04-08)2024-04-08
Jiangsu Meifan Biotechnology Co. Ltd. - FDA Warning Letter (2024-04-03)2024-04-03
FirstCham Co., Ltd. - FDA Warning Letter (2024-04-03)2024-04-03
Kilitch Healthcare India Limited - FDA Warning Letter (2024-03-28)2024-03-28
Bodywell Natural Skin Care Inc. - FDA Warning Letter (2024-03-27)2024-03-27
Sky Bank Media, LLC dba Painless Tattoo Cream Co. - FDA Warning Letter (2024-03-25)2024-03-25
Tattoo Numbing Cream Co. - FDA Warning Letter (2024-03-25)2024-03-25
Dermal Source, Inc. - FDA Warning Letter (2024-03-25)2024-03-25
SeeNext Venture, Ltd. - FDA Warning Letter (2024-03-25)2024-03-25
TKTX Company - FDA Warning Letter (2024-03-25)2024-03-25
Indelicare DBA INKEEZE - FDA Warning Letter (2024-03-25)2024-03-25
Antaria Pty. Ltd. - FDA Warning Letter (2024-03-22)2024-03-22
Betone S.A. de C.V. - FDA Warning Letter (2024-03-21)2024-03-21
Bret R. Rutherford, M.D. - FDA Warning Letter (2024-03-21)2024-03-21
New York State Psychiatric Institute IRB - FDA Warning Letter (2024-03-21)2024-03-21
Ammonia Sport Inc. - FDA Warning Letter (2024-03-19)2024-03-19
Deqing Jiarou Daily Chemical Co., Ltd. - FDA Warning Letter (2024-03-18)2024-03-18
Skull Smash LLC - FDA Warning Letter (2024-03-13)2024-03-13
Spirochaete Research Labs, LLC aka Scitus Laboratory Products - FDA Warning Letter (2024-03-08)2024-03-08
Native Salts LLC - FDA Warning Letter (2024-02-28)2024-02-28
Thai Nakorn Patana Co., Ltd. - FDA Warning Letter (2024-02-27)2024-02-27
Innovative Formulations, LLC dba Insane Labz - FDA Warning Letter (2024-02-22)2024-02-22
LightEyez Limited - FDA Warning Letter (2024-02-15)2024-02-15
Amman Pharmaceutical Industries - FDA Warning Letter (2024-02-14)2024-02-14
Salvacion USA Inc. - FDA Warning Letter (2024-02-13)2024-02-13
ivsupplyclinic.com - FDA Warning Letter (2024-02-09)2024-02-09
US Chem Labs - FDA Warning Letter (2024-02-07)2024-02-07
Synthetix Inc. DBA Helix Chemical Supply - FDA Warning Letter (2024-02-07)2024-02-07
Global Life Technologies Corp. - FDA Warning Letter (2024-02-06)2024-02-06
Sichuan Deebio Pharmaceutical Co. Ltd. - FDA Warning Letter (2024-02-05)2024-02-05
Ningbo Poplar Daily-Use - FDA Warning Letter (2024-02-05)2024-02-05
Ehy Holdings, LLC - FDA Warning Letter (2024-02-02)2024-02-02
Madhu Instruments Private Limited - FDA Warning Letter (2024-02-01)2024-02-01
Les Importations Herbasanté Inc. - FDA Warning Letter (2024-01-31)2024-01-31
S & J International Enterprises Public Company Limited - FDA Warning Letter (2024-01-26)2024-01-26
Sambrosa Care Inc. - FDA Warning Letter (2024-01-24)2024-01-24
Mei Lan Thailand Co., Ltd. - FDA Warning Letter (2024-01-22)2024-01-22
Glicerinas Industriales, S.A. de C.V. - FDA Warning Letter (2024-01-16)2024-01-16
Woorilife & Health - FDA Warning Letter (2023-12-28)2023-12-28
Botanical Be - FDA Warning Letter (2023-12-21)2023-12-21
Hua Da Trading, Inc. - FDA Warning Letter (2023-12-20)2023-12-20
Amazon.com, Inc. - FDA Warning Letter (2023-12-20)2023-12-20
Jeffrey W. Taub, M.D./Children's Hospital of Michigan - FDA Warning Letter (2023-12-19)2023-12-19
Patcos Cosmetics Pvt. Ltd. - FDA Warning Letter (2023-12-15)2023-12-15
www.trinexpharmacy.com - FDA Warning Letter (2023-12-14)2023-12-14
Anish S. Shah, M.D./Siyan Clinical Research - FDA Warning Letter (2023-12-12)2023-12-12
Novid Group, Inc. - FDA Warning Letter (2023-12-07)2023-12-07
Belmont Eyecare LLC - FDA Warning Letter (2023-12-01)2023-12-01
Dr. Berne’s Whole Health Products - FDA Warning Letter (2023-11-22)2023-11-22
Intas Pharmaceuticals Limited - FDA Warning Letter (2023-11-21)2023-11-21
Nantong Furuida Packaging Products Co., Ltd. - FDA Warning Letter (2023-11-17)2023-11-17
AmLion Toothpaste Mfg. Sdn. Bhd. - FDA Warning Letter (2023-11-17)2023-11-17
Cipla Limited - FDA Warning Letter (2023-11-17)2023-11-17
Discover Health, LLC d/b/a Discover CBD and Strain Snobs - FDA Warning Letter (2023-11-16)2023-11-16
Cerci Kozmetik Ve Otel Ekipmanlari Pazarlama Ic Ve Dis Ticaret Limited Sirketi - FDA Warning Letter (2023-11-16)2023-11-16
Xiamen Wally Bath Manufacture Co., Ltd. - FDA Warning Letter (2023-11-15)2023-11-15
Sudesan Temizlik Urunleri Ve Ambalaj Sanaryi Ticaret Anomin Sirketi - FDA Warning Letter (2023-11-13)2023-11-13
Amazon.com, Inc. - FDA Warning Letter (2023-11-13)2023-11-13
Melanie M. Hoppers, M.D./Physicians Quality Care - FDA Warning Letter (2023-11-08)2023-11-08
www.directpharmashop.net - FDA Warning Letter (2023-11-08)2023-11-08
Saruhan Kimya Ve Temizlik Urunleri Sanayi Ticaret Anonim Sirketi Corlu Subesi - FDA Warning Letter (2023-11-06)2023-11-06
Dexterity Health, LLC DBA Zazzee Naturals - FDA Warning Letter (2023-10-30)2023-10-30
Global Pharma Healthcare Private Limited - FDA Warning Letter (2023-10-20)2023-10-20
Samm Solutions, Inc., d.b.a. BTS Research - FDA Warning Letter (2023-10-20)2023-10-20
Maria W. Greenwald, M.D. - FDA Warning Letter (2023-10-20)2023-10-20
Sun Pharmaceutical Industries Ltd. - FDA Warning Letter (2023-10-16)2023-10-16
Handock Cosmetics Co., Ltd. - FDA Warning Letter (2023-10-04)2023-10-04
www.semaspace.com - FDA Warning Letter (2023-10-02)2023-10-02
www.gorillahealing.com - FDA Warning Letter (2023-10-02)2023-10-02
Seoul Cosmetics Co., Ltd. - FDA Warning Letter (2023-10-02)2023-10-02
www.alphamedstore.com - FDA Warning Letter (2023-09-29)2023-09-29
Antonio E. Blanco, M.D./Vista Health Research, LLC - FDA Warning Letter (2023-09-26)2023-09-26
Shot of Joy LLC - FDA Warning Letter (2023-09-25)2023-09-25
Luis Javier Pena-Hernandez, M.D., FCCP - FDA Warning Letter (2023-09-20)2023-09-20
Hygienic Labs, LLC - FDA Warning Letter (2023-09-19)2023-09-19
Zhao Qing Longda Biotechnology Co. Ltd. - FDA Warning Letter (2023-09-18)2023-09-18
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